Non-invasive prenatal testing is increasingly being adopted by high risk
pregnant women for the screening of common fetal chromosomal
aneuploidies such as Down syndrome (trisomy 21), Edwards syndrome
(trisomy 18), Patau syndrome (trisomy 13), Turner syndrome (monosomy X)
and many others. The non-invasive nature of these tests, their accuracy
and safety have been the major reasons behind their popularity among
gynecologists and expecting mothers.

MaterniT21 was the first NIPT launched in October 2011, by US based
Sequenom, Inc. and since then has been leading the market with the
largest market share. Harmony, verifi, Panorama, NIFTY, PrenaTest and
BambniTest are other commercially available NIPTs for detecting
chromosomal abnormaities.

The exponential growth of the NIPT market is supported by factors such
as high incidence rate of babies born with Down syndrome, no risk of
miscarriage with NIPT and shifting trend towards child bearing at
advanced maternal age (35 years or older). As maternal age is closely
associated with the increasing risk of developing a fetus with
chromosomal abnormalities, rising maternal age is likely to contribute
to the increasing incidence of babies born with chromosomal aneuploidies.

According to Down syndrome education (DSE), in the US, the incidence
rate for Down syndrome is 1 in every 830 child births (around 4,700
annually), while in Europe the incidence rate is 1 in every 920 babies
born (around 9,000 annually), indicating a large potential consumer base
for NIPT.

Conventional invasive prenatal genetic tests such as amniocentesis and
chorionic villus sampling (CVS) are associated with the chance of
miscarriage, which is the prime reason for their replacement with new
non-invasive prenatal tests. These new NIPTs are based on the analysis
of cell-free DNA floating in the maternal plasma and pose no risk of
miscarriage.

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